In September 2024, Pfizer, the manufacturer of Oxbryta, voluntarily recalled the drug, completely removing it from the market. The United States Food and Drug Administration (FDA) had approved Oxbryta to treat and manage sickle cell disease under the Accelerated Approval Program in 2019. But after conducting postmarketing clinical trials, Pfizer determined that the medication caused severe side effects and concluded that the drug’s benefits didn’t outweigh the risks. Pfizer voluntarily withdrew Oxbryta from the market following the safety concerns and regulatory scrutiny. The recall, announced on September 25, 2024, was due to emerging data showing increased risks of vaso-occlusive crises and fatalities among patients.
The Oxbryta recall came following shocking findings from postmarketing clinical trials linking it to adverse side effects, including increased hospitalizations, vaso-occlusive cases, and even death. The European Medicines Agency (EMA) played a significant role in reviewing Oxbryta’s safety and contributed to the regulatory actions taken. The EMA recommended the suspension of Oxbryta’s marketing authorization due to safety concerns, aligning with Pfizer’s decision to withdraw the drug from the market.
What Is Oxbryta (Voxelotor) and Why Was It Approved?
The prescription medication Voxelotor, branded Oxbryta by its manufacturer, Global Blood Therapeutics, an affiliate of Pfizer, was a groundbreaking sickle cell drug. Oxbryta was developed as medication to treat sickle cell disease, a genetic blood disorder.
Sickle cell disease is a hereditary blood disorder characterized by abnormal production of hemoglobin.
Oxbryta works by enhancing hemoglobin’s ability to carry oxygen, which helps maintain proper blood flow and reduces the risk of complications. Oxbryta reduces hemolysis, thereby improving hemoglobin’s ability to bind oxygen.
This was an effective way to treat and manage sickle cell disease, a hereditary condition in which sickle-shaped red blood cells can block blood vessels due to abnormalities in hemoglobin, reducing blood circulation and hindering the delivery of essential nutrients and oxygen to vital organs. Oxbryta was marketed as a breakthrough treatment for sickle cell disease, aiming to improve oxygen flow and reduce painful vaso-occlusive crises. This can cause other medical issues, including:
- Dizziness
- Anemia
- Stroke
- Sharp pains in the joints
- Severe and chronic inflammation
- Swelling in the extremities
- Infections
- Organ damage from reduced blood circulation and oxygen deprivation
- Vaso occlusive crises (VOCs), which are severe and painful complications caused by sickled red blood cells blocking blood vessels, leading to severe pain.
Sickle cell disease worsens with age and can adversely affect the joints and other body organs.
Currently, there’s no cure for this debilitating health condition. The few sickle cell disease management options focus on reducing the damage sickle cells cause, mitigating the risks of complications associated with the disease, including anemia and stroke, and managing the chronic pain caused by the devastating condition. Blood transfusions are sometimes used as part of sickle cell disease treatment to reduce the risk of stroke and organ damage.
That’s why it was great news when the FDA granted Oxbryta accelerated approval in November 2019 to treat and manage sickle cell disease in the United States for patients aged 12 years or older. In 2021, the government agency expanded Oxbryta’s accelerated approval for use in patients aged between 4 and 11 years.
However, as part of the approval, the FDA required Pfizer to perform additional postmarketing clinical trials to ensure the medication was effective and not harmful to those taking it.
What Went Wrong: Safety Concerns and the Oxbryta Recall
On September 25, 2024, the United States Food and Drug Administration announced that Pfizer had recalled Oxbryta from the market. The giant pharmaceutical company recalled Oxbryta from the market because data from postmarketing studies found that there were more fatalities in patients who took the sickle cell disease medication compared to those who took a placebo. In these studies, patients taking Oxbryta compared to the placebo group experienced more adverse events, raising significant safety concerns. Oxbryta’s accelerated approval was based on a single clinical trial with 274 participants, which showed initial promise but did not fully assess long-term safety and efficacy.
Pfizer announced that two postmarketing studies showed alarming findings linking Oxbryta to a surge in chronic pain and fatalities among patients. The studies showed that the sickle cell disease drug doubled the rates of vaso-occlusive crises and deaths in patients taking the medication.
The clinical trials were observational, and there was no definitive evidence proving that Oxbryta directly caused the fatalities in those trials, as most of the death cases were because of infections like sepsis and malaria. However, ongoing clinical trials and active clinical trials were halted due to the increased risk of severe complications and the number of patients who experienced severe complications among patients taking Oxbryta.
Medical researchers suspended both clinical trials, and Pfizer issued a global market withdrawal of the medication. Following the recall, healthcare professionals were advised to stop prescribing Oxbryta to prevent further adverse events.
The Legal Claims: What Plaintiffs Are Alleging in the Oxbryta Lawsuits
The Oxbryta lawsuits are seeking monetary compensation from Pfizer and its affiliate Global Blood Therapeutics. The Pfizer Oxbryta recall & litigation alleges that the pharmaceutical companies acted negligently while manufacturing and selling the sickle cell disease drug. That includes how they produced, tested, marketed, labeled, and sold the medication.
The lawsuits primarily involve claims of negligence and product liability due to increased risks revealed by post-market data. Patients who experienced severe complications after taking Oxbryta are filing lawsuits against Pfizer, claiming that the company did not properly disclose the risks associated with the drug.
Legal claims in Oxbryta lawsuits include:
- Design defects: Pfizer and its subsidiary, Global Blood Therapeutics, alleged that the medication reduced sickling and helped blood cells deliver more oxygen. However, the drug reduces oxygen delivery and causes chronic pain.
- Failure to adequately warn patients and doctors of the potential dangers of their products: Defendants were aware or should have been aware of the possible risks of Oxbryta. Yet they didn’t sufficiently warn the public.
- False and misleading advertising: Pfizer marketed Oxbryta with allegations that it would minimize sickling by addressing the condition at its source. However, the company was aware that the allegations were misleading and false.
- Negligence: Plaintiffs claim that defendants didn’t sufficiently test and study the medication before selling it.
- Unjust enrichment: Plaintiffs also claim that the defendants profited from selling a drug they knew was dangerous.
- Breach of warranties: Plaintiffs further allege that defendants had promised that the medication would work as intended in its labelling, marketing, and other materials. However, it was harmful, defective, and unsafe for human consumption.
Oxbryta lawsuits seek financial compensation to cover current and future damages, including medical expenses and both physical and emotional suffering. The amounts are to be determined at trial.
Additionally, they seek reimbursement for losses related to lost income, pain and suffering, and wrongful death. Furthermore, the Oxbryta lawsuits seek punitive damages to punish the defendants and to recover case-related expenses and attorneys’ fees.
Who Might Be Eligible to Join an Oxbryta Lawsuit?
If you took Oxbryta and developed health complications like increased vaso-occlusive events, organ failure, or even suffered a stroke, you may qualify to file an Oxbryta injury claim. Affected patients and Oxbryta users who experienced Oxbryta injuries or health risks associated with the drug may also be eligible to join the lawsuit.
Those who developed adverse health conditions while taking the drug and the families of deceased persons might qualify to file Oxbryta side effects wrongful death claims.
Here’s what you should know to determine if you meet the eligibility criteria to file an Oxbryta lawsuit:
- You took the medication to treat and manage sickle cell disease
- You suffered from organ failure, a heart attack, or a stroke shortly after taking Oxbryta
- You weren’t warned about the possible dangers of the medication.
If any of these apply to your circumstances, you may be entitled to pursue Oxbryta compensation to cover your medical bills, lost earnings, pain and suffering, and even the wrongful death of a loved one.
Don’t wait–time is crucial in product liability lawsuits like this one, and your legal rights and ability to pursue compensation might be at risk.
How to File a Claim an Oxbryta Claim: Step by Step
Did you develop adverse injuries after taking the sickle cell disease medication? Then, you should talk with a skilled product liability lawyer who specializes in defective medication lawsuits. These lawsuits are complex and involve giant pharmaceutical companies with their own attorneys.
Key steps in Oxbryta lawsuits:
- Gather evidence: Compile your medical documents that prove medical professionals diagnosed you with sickle cell disease and prescribed you to take Oxbryta, and that you developed serious injuries after taking the medication. Collect comprehensive medical records, as these documents establish your condition, adverse events, and the link to Oxbryta.
- Consult an attorney: Look for a skilled product liability lawyer specializing in medication injury lawsuits. It is important to work with experienced attorneys, who understand the complexities of pharmaceutical litigation and can effectively pursue your claim. These lawyers often work on contingency fees, which means they only get paid if you receive compensation. At Allconsumer.com, we partner with various personal injury lawyers specializing in dangerous drug lawsuits and can help you find the right lawyer for your case.
- Send a demand letter: Your attorney will collect evidence, such as medical reports and bills, and send a letter to Pfizer demanding monetary compensation. Your product liability lawyer will also negotiate for the best settlement amount.
- File an Oxbryta lawsuit: If negotiations fail, your attorney will file a lawsuit in court. This legal complaint outlines your allegations, the damages you seek, and the relevant facts supporting your claims.
- The discovery stage: Your attorney and the defense team will exchange evidence, interview expert witnesses, and prepare for trial.
- Settlement or trial: Your attorney and the defense team might agree to resolve your lawsuit through a settlement. If not, your attorney will present your lawsuit in court for a judgment.
Don’t forget that you have a limited time to file an Oxbryta injury lawsuit. That’s because of the statute of limitations, which varies from state to state. Some states allow for one year from the time you discover your injuries, so file as soon as possible.
What to Expect: Timeline, Settlement Options & Trial Dates
As of November 21, 2025, Oxbryta mass tort litigation is still in the early phases. So far, there have been no verdicts, trials, or publicly announced settlement payouts. Attorneys have accepted and filed Oxbryta injury claims in federal and state courts on behalf of clients from several states, including California and Illinois.
In June 2025, the California federal court scheduled a trial date in 2027 for an Oxbryta injury lawsuit. The upcoming Oxbryta trial is a significant milestone in the litigation process, as it will test the evidence against Pfizer and could impact future settlement prospects and legal strategies. The first trial in the Oxbryta litigation is scheduled for August 16, 2027, in San Francisco. Settlement negotiations for Oxbryta lawsuits are scheduled to begin, with mediation set for September 9, 2025.
It’s not clear how widely the drug was used while it was on the market before the voluntary recall. Furthermore, it’s crucial to note that Oxbryta was the first drug to target the actual cause of sickle cell disease— an inherited blood disorder affecting nearly 8 million people — therefore, many people likely used it. So, there’s potential for a huge surge in lawsuits.
Legal experts predict that Oxbryta settlement amounts will range from $50,000 to $1 million, depending on the specifics of each lawsuit. It’s important to note that these figures aren’t definitive, as each lawsuit is unique. Settlement amounts are expected to vary further based on the severity of injuries and the impact on patients’ lives, with some estimates reaching up to $1.5 million or more.
Since lawyers are still filing initial Oxbryta lawsuits in both federal and state courts, the JPML, or Judicial Panel on Multidistrict Litigation, may eventually consolidate these claims into multidistrict litigation (MDL) if there are many cases. The Oxbryta litigation may evolve into a multidistrict litigation (MDL) to streamline the legal process and consolidate similar claims against Pfizer.
What Should You Do Now? Deadlines, Evidence, and Legal Help
If you or a family member were prescribed Oxbryta, the first and crucial step to take is to contact your doctor immediately. Stopping a prescription medication should always be done after consulting with a doctor, particularly if you’re managing adverse conditions like sickle cell disease. Suddenly stopping taking Oxbryta without medical supervision may cause complications because your body might need to adjust to treatment changes.
The FDA recommends that you work closely with your doctor to find alternative treatment options that are better and safer. Various FDA-approved drugs are available to treat and manage sickle cell disease. Your doctor can help determine the best alternative depending on your current health status and medical history.
Next, collect all documentation demonstrating your medical history and Oxbryta usage, including:
- Medical documents: Collect all documents detailing your medical diagnosis, lab results, treatment plans, doctor’s notes, and imaging scans, particularly those detailing your injuries, like organ damage, vaso-occlusive crises, and stroke.
- Track expenses and financial impact: Keep a comprehensive journal of symptoms and how the side effects have impacted your daily life, finances, and work. Record all costs, such as lost earnings and medical bills.
- Prescription history: Gather prescription documentation and pharmacy receipts as evidence that you used Oxbryta as prescribed.
Finally, consult a qualified Oxbryta side effects lawyer: Engaging a skilled personal injury attorney is a fundamental step for sickle patients pursuing Oxbryta settlement amounts, because an attorney can ensure your lawsuit aligns with legal standards.
Lawyers specializing in pharmaceutical claims have the experience and knowledge required to navigate the complexities of lawsuits involving pharmaceutical companies.
Additionally, lawyers understand the technical evidence required and can identify the most effective legal approaches to prove liability and demonstrate injury. Furthermore, lawsuits against pharmaceutical companies involve strict procedural requirements, such as jurisdictional rules, statutes of limitations, and evidentiary standards, particularly when a defective medication is used. A skilled personal injury lawyer ensures that you meet all these requirements, preventing dismissals or delays because of technical errors.
Moreover, a qualified attorney can help you meet the statute of limitations for filing an Oxbryta claim. Generally, the statute of limitations for filing an Oxbryta injury claim varies by state, typically ranging from 1 to 4 years. This time limit usually starts from the date your injuries occurred or from when you discovered them.
If you or a family member has experienced adverse health conditions after taking Oxbryta, don’t face the complex legal process alone. Contact an experienced attorney today to learn your legal options.
At Allconsumer.com, we partner with several personal injury attorneys who can help you file your Oxbryta lawsuit and pursue the monetary compensation you’re entitled to. Contact us today to learn how we can help you.
